Ecg lead wire organizer and dispenser

ABSTRACT

An ECG lead set including an ECG electrode assembly and a lead set hub. ECG electrode includes at least one electrode configured to receive biopotential signals from a patient, a plug connector for connecting said ECG electrode assembly, a web, connected between the at least one electrode and the plug connector and configured to form an electrical connection therebetween. The lead set hub includes at least one receptacle configured to receive the plug connector of the ECG electrode assembly.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This patent application claims priority to and the benefit of U.S.Provisional Patent Application No. 60/872,815 filed in the U.S. Patentand Trademark Office on Dec. 5, 2006.

BACKGROUND

1. Technical Field

The present disclosure relates to medical equipment. In particular, thepresent disclosure relates to an ECG lead wire organizer and dispenser,and methods for use thereof.

2. Description of Related Art

Electrocardiograph (ECG) monitors and recorders (hereinafter “ECGMonitors”) are widely used to obtain biopotential signals containinginformation indicative of the electrical activity associated with theheart and pulmonary system. To obtain biopotential signals, ECGelectrodes are applied to the skin of a patient in various locations andcoupled to an ECG monitor. Placement of the electrodes is dependant onthe information sought by the clinician.

The placement of the ECG electrodes on the patient has been establishedby medical protocols. The most common protocols require the placement ofthe electrodes in a 3-lead, a 5-lead or a 12-lead configuration. A3-lead configuration requires the placement of three electrodes; oneelectrode adjacent each clavicle bone on the upper chest and a thirdelectrode adjacent the patient's lower left abdomen. A 5-leadconfiguration requires the placement of the three electrodes in the3-lead configuration with the addition of a fourth electrode adjacentthe sternum and a fifth electrode on the patient's lower right abdomen.A 12-lead configuration requires the placement of 10 electrodes on thepatient's body. Four electrodes, which represent the patient's limbs,include the left arm electrode (LA), the right arm electrode (RA), theleft leg electrode (LL), and the right leg electrode (RL). Six chestelectrodes (V1-V6 leads) are placed on the patient's chest at variouslocations near the heart. Three additional references are constructedfrom measurements between the right arm and left arm (Lead I), the rightarm and the left leg (Lead II) and the left arm to left leg (Lead III).The ten electrodes provide 12 measurement points consisting of I, II,III, AVR, AVL, AVF, and V1-V6 with the right leg electrode typicallyused as a ground.

The electrodes, after being positioned on the patient, connect to an ECGmonitor by an ECG lead set. The distal end of the ECG lead set, orportion closest to the patient, connects to each electrode(alternatively, the electrodes may be integrated into the distal end ofthe ECG lead set) and receives biopotential signals from the body. Theproximal end of the ECG lead set connects to the ECG input connector andsupplies the biopotential signals received from the body to the ECGmonitor.

Proper placement of the ECG electrodes and proper connections of the ECGelectrodes to the ECG lead sets is critical for obtaining the correctbiopotential signals. Clinicians often have difficulty connecting ECGlead sets to ECG electrodes because the individual wires of the ECG leadset often become entangled or because the clinician must determine whichindividual wire connects to each electrode. In addition, the individualwires of the ECG lead sets are often long and cumbersome resulting inpatient discomfort.

Issues with placement of electrodes and connection of the ECG lead setare often compounded during emergency situations. First responders andclinicians often place ECG electrodes on accident victim or heart attacksufferers to establish the medical condition. Any delay may result inadverse consequences. Other emergency treatments may require the rapidremoval of ECG electrodes further compounding the issues withentanglement and re-connection.

During use, individual electrodes or one or more of the individual wiresof the ECG lead sets may become damaged. Individual electrodes may bereplaced provided the ECG lead set connects to the electrodes via anelectrode connector. Individual wires of the ECG lead set sometimescannot be replaced and damage thereof may require the replacement of theentire ECG lead set.

The present application provides an ECG lead set organizer, dispenserand methods of use thereof that preventing the aforementioned problems.

SUMMARY

The present disclosure relates to medical equipment. In particular, thepresent disclosure relates to an ECG lead set organizer, dispenser andmethods of use thereof. In accordance with one preferred embodiment, anECG lead set apparatus includes a lead set hub adapted for electricalconnection to a biomedical device and being adapted for positioningrelative to a patient and at least one lead wire having hub end forreleasable connection to the lead set hub and an electrode at anotherend for receiving biopotential signals from the patient. Thebiopotential signals are transmittable through the lead set hub toprovide biomedical information to the biomedical device. A plurality oflead wires may be provided with each lead wire having an electrode. Atleast one lead wire defines an effective length between the hubconnector and the electrode with the effective length being adjustable.A slide adjuster may be mounted about the lead wire. The slide adjusteris adapted to slide along the lead wire to adjust the effective length.The slide adjuster may be a buckle member.

At least one lead wire may be extensible. The at least one lead wire mayinclude a general serpentine arrangement adapted to flex toward a lineararrangement to thereby adjust the effective length thereof. The at leastone lead wire may be encased within an insulative cover. The at leastone wire may be adapted to flex toward the linear arrangement within theinsulative cover. The insulative cover may be adapted to stretch.

In another embodiment, the lead set hub may include an electrode mountedthereto. A plurality of electrodes may be mounted to the lead set hub.An electrode array may be connectable to the lead set hub. The electrodearray may include a substrate and a plurality of electrodes mounted tothe substrate.

As a further alternative, a clamp may be mounted to the lead set hub.The clamp has a receptacle for reception of the hub end of the at leastone lead wire. The clamp is movable from an initial position to aclamping position to secure the hub end to the lead set hub andestablish electrical connection between the electrodes and thebiomedical device. The clamp includes a conductive terminal adapted toelectrically contact the at least one lead wire upon movement of theclamp to the clamping position. The at least one lead wire may includean insulating cover. The clamp may include a penetrating member adaptedto penetrate the insulating cover upon movement of the clamp to theclamping position to permit the conductive terminal to electricallycontact the at least one lead wire. The penetrating member may beadapted to sever the at least one lead wire upon movement of the clampto the clamping position.

In another embodiment, an ECG lead set apparatus includes a lead set hubadapted for electrical connection to a biomedical device and beingadapted for positioning relative to a patient, at least one lead wirehaving hub end for connection to the lead set hub and an electrode atanother end for receiving biopotential signals from the patient. Thebiopotential signals are transmittable through the lead set hub toprovide biomedical information to the biomedical device. A reel isdisposed within the lead set hub and houses the at least one lead wire.The at least one lead wire is releasable from the reel to vary theeffective length between the electrode and the lead set hub.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the present disclosure are described herein withreference to the drawings wherein:

FIG. 1 is a schematic illustrating an ECG monitoring systemincorporating an ECG monitor and an ECG lead set assembly in accordancewith the present disclosure and disposed on a patient;

FIG. 1A is another schematic illustrating an alternate arrangement of anECG lead set assembly of the ECG monitoring system of FIG. 1;

FIG. 2A is a perspective view of one embodiment of an ECG electrode leadof the ECG lead set assembly of FIG. 1;

FIG. 2B is a cross-sectional view of the ECG electrode lead of FIG. 2A;

FIG. 2C is a perspective view of another embodiment of an ECG electrodelead for use with the ECG lead set assembly;

FIG. 3A is a perspective view of another embodiment of an ECG electrodelead useable with the ECG lead set assembly of FIG. 1;

FIG. 3B is a cross-sectional view of the ECG electrode lead of FIG. 3A;

FIG. 3C is a plan view of a tri-slide adjuster for use with the ECGelectrode lead;

FIGS. 3D-3E are cross-sectional views illustrating the use of thetri-slide adjuster of FIG. 3C adjusting the length of the signalconducting web;

FIG. 4A is a schematic illustrating an alternate embodiment of an ECGlead set assembly including the ECG electrode lead of FIG. 2C disposedon a patient;

FIG. 4B is a schematic illustration of another embodiment of an ECG leadset assembly including extendable ECG electrode leads disposed on apatient;

FIG. 4C is a schematic illustration of another embodiment of an ECG leadset including the extendable ECG electrode assemblies of FIG. 4B, anelectrode lead set hub and an electrode array;

FIG. 5A is a schematic illustration of another embodiment of an ECG leadset assembly including stretchable ECG electrode leads;

FIGS. 5B-5D are schematics illustrating alternate embodiments ofstretchable ECG electrode leads useable with the ECG lead set assemblyof FIG. 5A;

FIG. 6 is a schematic illustrating an ECG lead set assembly including alead set hub with clamp receptacles;

FIG. 7A is a an exploded view of the ECG electrode assembly of FIG. 6;

FIG. 7B is a schematic illustrating a method of manufacturing the ECGelectrode assemblies of FIG. 7A;

FIG. 8 is a cross-sectional view of the clamp receptacle of the lead sethub of FIG. 6;

FIG. 9 is a schematic view illustrating another alternate embodiment ofan ECG lead set assembly disposed on a patient;

FIGS. 10A-10D are schematics illustrating the lead set hub and the ECGelectrode leads of FIG. 9; and

FIG. 11 is a side view of an embodiment of a central post for use withthe lead set hub of the lead set assembly of FIG. 9;

FIG. 12 is a side view with portions cut away of the central post ofFIG. 11; and

FIG. 13 is a schematic illustrating an alternate embodiment of a leadset hub for use with the electrode lead set assembly of FIG. 9.

DETAILED DESCRIPTION

Particular embodiments of the present disclosure are describedhereinbelow with reference to the accompanying drawings. In thefollowing description, well-known functions or constructions are notdescribed in detail to avoid obscuring the present disclosure inunnecessary detail. As used herein and as is traditional, the term“distal” refers to the portion which is furthest from the user/clinicianand the term “proximal” refers to the portion that is closest to theuser/clinician. In addition, terms such as “above”, “below”, “forward”,“rearward”, etc. refer to the orientation of the figures or thedirection of components and are simply used for convenience ofdescription.

FIG. 1 illustrates, in schematic view, an ECG monitoring system 10 inaccordance with the principles of the present disclosure. ECG monitoringsystem 10 includes ECG monitor 20 and ECG lead set assembly 100 inelectrical communication with the ECG monitor 20. ECG monitor 20 isconfigured to receive biopotential signals containing informationindicative of the electrical activity associated with the heart andpulmonary system and to display the information on user display 22. ECGmonitor 20 include at least one lead set input connector 24 configuredto connect to at least one ECG lead set assembly 100 through cable 140.Connector 130 on the proximal end of cable 140 electrically and/ormechanically connects lead set assembly 100 to ECG monitor 20.Alternatively, connector 130 may connect to ECG monitor 20 through anadapter (not shown).

ECG lead set assembly 100 includes lead set hub 110 and one or more ECGelectrode leads 120 a-e releasably connected to the lead set hub 110.ECG electrode leads 120 a-e has electrodes 121 a-e respectivelyconnected thereto. Electrodes 121 a-e may be individual componentsreleasably connectable to electrode leads 120 a-e via suitable electrodeconnectors. Alternatively, the electrodes 121 a-e may be integrallyformed as an integral component of the respective electrode leads 120a-e. In the illustrated embodiment, ECG lead set assembly 100 isconfigured in a 5 lead configuration. However, ECG lead set 100 may beconfigured in any suitable configurations. Cable 140 is connected tolead set hub 110 through a suitable electrical connector or adapter.FIG. 1A illustrates one arrangement of the ECG lead set 100 suitable ina 5 lead ECG configuration.

Referring now to FIGS. 1 and 2A-2B, in one embodiment, lead set hub 110includes at least one, preferably, a plurality of, receptacles 150 a-econfigured to releasably connect to respective ECG electrode leads 120a-e. The proximal end of each of ECG electrode leads 120 a-e detachablyconnects to a corresponding receptacle 150 a-e on lead set hub 110. Anexemplative ECG electrode lead 220 a depicted in FIGS. 2A-2B includesplug assembly 222, slide adjuster 127 a, conductive signal conductingweb 229 and electrode 221. Plug 222 includes electrical contact 225disposed on tab 223 and plug barrel 226 disposed in barrel housing 224.Tab 223 detachably connects to receptacle 150 on lead set hub 110.Electrical contact 225 forms an electrical connection between lead sethub 110 and ECG electrode lead 220 a. Tab 223 in FIG. 2A forms aninterference fit connection with receptacle 150 and secures tab 223 inreceptacle. The interference fit is adapted to provide a sufficientelectrical connection between electrical contact 225 and lead set hub110. Other suitable means of connection may be used, such as, forexample, a locking-tab connection, a barrel/pin connection, or a snapconnection.

Web 229 connects to barrel housing 224 of plug assembly 222 andelectrically connects to electrical contact 225 through barrel housingand tab 223, thus forming an electrical connection between electrode 221and the electrical contact 225. Web 229 is capable of forming a bendingradius equal to the radius of the adjustment slide barrel 228 a. Web 229may be a single or multi-conductor ribbon cable, with at least oneelectrical trace printed on a flexible substrate or any other suitablewire or ribbon-type cable.

Slide adjuster 127 includes adhesive pad 127 a for securing slideadjuster 127 to patient skin, web guide 228 and adjustment slide barrel228 a housed in the web guide 228. Web guide 228 positions and/or guidesweb 229 through slide adjuster 127. Slide adjuster 127 is slidablydisposed on web 229. Web 229 is received within web guide 228 and atleast partially wraps around adjustment slide barrel 228 a.

The distance “d1” between electrode 221 and plug 222 may be adjusted bypositioning slide adjuster 127 relative to the plug 222. Decreasing thedistance “d2” between slide adjuster 127 and plug 222 increases thedistance “d1” between the electrode 221 and the plug 222. Increasing thedistance “d2” between slide adjuster 127 and plug 222 decreases thedistance “d1” between the electrode 221 and the plug 222.

ECG electrode lead 220 a in FIGS. 2A and 2B is configured such that web229 at least partially wraps around each of adjustment slide barrel 228a and plug barrel 226. The distance “d1” between electrode 221 and plug222 may be adjusted between a length about equal to the length of web229 to a distance about equal to a third of the length of the web 229.

In use, again with reference to FIGS. 1 and 2A, lead set hub 110 isdisposed on the chest of the patient “p”. Lead set hub 110 may bedisposed on patient “p” or may be adhered to patient “p” with a suitablematerial, such as, for example, adhesive or conductive hydrogel.Alternatively, the bottom or patient side of lead set hub 110 mayinclude a medical electrode (not shown), and that secures the lead sethub 110 to patient “p”.

Tab 223 of plug 222 on each ECG electrode leads 120 a-e connects to areceptacle 150 a-e of lead set hub 110 and electrodes 121 a-e aredisposed on the patient “p”. Slide adjuster 227 of each ECG electrodelead 120 a-e is positioned such that the length of the ECG electrodelead 120 a-e is customized to fit the patient “p” and adhesive pad 227 aon slide adjuster is adhered to patient “p”.

The clinician may replace or remove any of the individual ECG electrodeleads 120 a-e of the ECG lead set assembly 100 without replacing theentire lead set. For example, if any ECG lead 120 a-e is found to bemalfunctioning, the clinician may remove the ECG lead 120 a-e andreplace it with another lead 120 a-e. The clinician may also disconnectthe individual ECG electrode lead 120 a-e from receptacles 150 a-e oflead set hub 110 during medical procedures that require isolation of ECGelectrodes 121 a-e.

While plug 222 is configured to be removable from receptacle 150 a-e,and is therefore reusable, it is desirable to limit the reusability ofECG electrode lead 120 a-e and/or lead set hub 110 to a single patientto prevent cross-contamination or re-use. Plug 222 and/or receptacle 150a-e may be configured to limit the number of times they may be reused.Mechanical wear between receptacle 150 a-e and electrical contact 225 orreceptacle 150 a-e and/or plug 222 may limit the number of uses, orreceptacle 150 a-e and/or plug 222 may be configured to fail after asingle use.

Various other suitable configurations may be used to provideadjustability of the lengths of ECG electrode lead 120 a-e. ECGelectrode lead 220 c illustrated in FIG. 2C includes first and secondslide adjusters 227 b, 227 c. Web 229 connects to plug assembly 222 c onthe proximal end, passes through first slide adjuster 227 b, at leastpartially wraps around second adjustment slide barrel 228 c, at leastpartially wraps first adjustment slide barrel 228 b and passes throughthe second slide adjuster 227 c. On the distal end, web 229 connects toelectrode 221 or to a suitable electrode connector (not shown).

Plug assembly 222 c of FIG. 2C consists of tab 223 c and electricalcontact 225 c and is smaller in size than plug assembly 222 of ECGelectrode lead 220 a of FIGS. 2A and 2B, and thus tab 223 c presents asmaller profile when positioned on the patient. The distance betweenelectrode 221 and plug 222 c may be adjusted to a length about equal tothe length of the web 229 to a distance about equal to a third of thelength of the web 229.

FIGS. 3A-3B illustrate yet another embodiment of an ECG electrode leadof the present disclosure. ECG electrode lead 320 includes one or morebuckle-type slide adjusters 327 a, 327 b configured to guide and/orposition the web. Buckle-type slide adjuster 327 a, 327 b form one ormore slots 328 a-d. Web 329 passes through a first slot 328 a of firstbuckle-type slide adjuster 327 a, through first slot 328 c of secondbuckle-type slide adjuster 327 b, through second slot of the firstbuckle-type slide adjuster 327 a and through second slot of the secondbuckle-type slide adjuster 327 b.

Buckle-type slide adjusters 327 a, 327 b are configured to provide ameans of adjusting the length of the ECG electrode lead 320. The lengthof the ECG electrode lead 320 may be adjusted to a length about equal tothe length of web 329 to a length about equal to a third of the lengthof the web 329.

At least a portion of buckle type slide adjuster 327 a, 327 b adjacentto patient's skin may include a coating and/or layer of a suitableadhesive or gel material configured to adhere to the patient's skin. Theproximal portion adhesive layer 330 a of first buckle-type slideadjuster 327 a and middle portion adhesive layer 330 b of secondbuckle-type slide adjuster 327 b attach each of buckle-type slideadjusters 327 a, 327 b to patient skin and may prevent furtheradjustments to the length of the ECG electrode lead 320. Buckle-typeslide adjuster 327 a, 327 b may include a snap-down locking device (notshown) to further prevent the further adjustments to the length of theECG electrode lead 320.

Alternatively, ECG electrode assembly may include a single buckle with asecond adjuster incorporated into the plug, similar to plug 222illustrated in FIGS. 2A and 2B. A single buckle may allow one-handedadjustment to the length of the ECG electrode assembly.

FIGS. 3C-3E illustrate yet another embodiment of slide adjusters thatmay be used with an ECG electrode lead set assembly of the presentdisclosure. FIG. 3C is a plan view of tri-slide adjuster 340 thatincludes a tri-slide housing and first, second and third tri-slidebarrels 340 a-c. FIGS. 3D and 3E illustrate an ECG electrode assembly320 including two tri-slide adjusters 340.

In FIG. 3D, first and second tri-slide adjusters 340 a, 340 b arepositioned perpendicular to web 329 and web 329 slides freely throughand around the tri-slide barrels 326 a-c of the tri-slide adjusters 340a, 340 b. The length of the ECG electrode lead 320 may be adjusted byvarying the distance between the first and second tri-slide adjusters340 a, 340 b.

In FIG. 3E, first and second tri-slide adjusters 340 a, 340 b are notpositioned perpendicular to web 329. Tri-slide adjusters 340 a, 340 bnot positioned perpendicular to web 329 restrict the web 329 andprohibit adjustment to the length of the ECG electrode assembly 320.

Referring now to FIG. 4A, another embodiment of ECG lead set 400according to the present disclosure is illustrated. FIG. 4A illustratesECG lead set 400 with four ECG electrode leads 420 a-d of FIG. 2Cconnected to lead set hub 410. Receptacles 450 a-d on lead set hub 410 aare configured to receive the plug assembly (not shown) of ECG electrodeleads 420 a-d. Electrodes 421 a-e are disposed on patient “p” and firstand second slide adjusters 227 a, 227 b are positioned to take up accessweb 229. The 5 electrodes 421 a-e of the ECG lead set 400 are configuredin a 5 lead configuration. ECG lead set 400 may be configured in othersuitable configurations.

FIG. 4B illustrates ECG lead set 401 with four extendable ECG electrodeleads 460 a-d connected to lead set hub 410 and cable 440. The 5electrodes 421 a-e of the ECG lead set 401 are configured in a 5 leadconfiguration. ECG lead set 401 may be configured in other suitableconfigurations.

Extendable ECG electrode assemblies 460 a-d may be formed from aflexible substrate die cut into a serpentine pattern with an electricaltrace printed onto the substrate. Substrate may be extended to providesufficient length for placement of electrodes 421 a-d away from lead sethub 410 b. Alternatively, extendable ECG electrode leads 460 a-d may beformed from a suitable serpentine-shaped cable. Extendable ECG electrodeleads 460 a-d may include additional layers to provide EMI shielding.Extendable ECG electrode leads 460 a-d may be formed to any suitablelength.

FIG. 4C illustrates an ECG lead set 402 with the extendable ECGelectrode leads 460 a-d from FIG. 4B, electrode lead set hub 410 c,cable 440 and electrode array 462 configured to connect to the electrodelead set hub 410 c. The 10 electrodes 421 a-j of the ECG lead set 402are configured in a 12-lead configuration. ECG lead set 402 may beconfigured in other suitable configurations.

Electrode lead set hub 410 c includes one or more electrode tabs 421 e,421 f. configured to attach to patient “p” and receive electricalsignals. Electrode tabs 421 e, 421 f may be integrated into a disposableelectrode lead set hub 410 c. Alternatively, electrode lead set hub 410c may be reusable and electrode tabs 421 e, 421 f may be electricallyand/or mechanically attached to electrode lead set hub 410 c. Means ofattachment may be adhesive, hook-and-loop fasteners, slotted tabs, anelectrical plug and receptacle or any other suitable means ofelectrically and mechanically attaching an electrode.

Electrode array 462 includes one or more electrode 421 g-j disposed on aflexible substrate and configured to receive electrical signals frompatient “p”. Electrode array 462 may include extendable portion 462 bconfigured to extend to electrode lead set hub 410 c. Electrode arrayreceptacle 462 a is configured to receive plug (not shown) on theproximal end of extendable portion 462 b of electrode array 462.Electrode array receptacle 462 a may receive a plurality of electricalsignals from electrodes 421 g-j on electrode array 462.

Application of the ECG lead set 402 is effected by first disposingelectrode lead set hub 410 c on the center chest portion of patient “p”.Backing (not shown), if present, of each electrode tab 421 e, 421 f isremoved and electrode tabs 421 e, 421 f are applied to patient “p” skin.After electrode lead set hub 410 c is disposed, clinician applies one ormore electrode 421 g-j of electrode array 462 to patient. If necessary,extendable portion 462 b of electrode array 462 is extended to enableconnecting the plug (not shown) on the proximal end of electrode array462 to connect to electrode array receptacle 462 b. Electrodes 421 a-dof extendable ECG electrode leads 460 a-d are positioned on patient “p”,extended (if necessary) and attached to receptacles 450 a-d on electrodelead set hub 410 c.

FIG. 5A illustrates an ECG lead set assembly 500 with stretchable ECGelectrode leads 560 a-d. ECG lead set 500 includes lead set hub 510,cable 540 and a one or more stretchable ECG electrode assemblies 560a-d. The 5 electrodes 521 a-e of the ECG lead set 402 are configured ina 5 lead configuration. ECG lead set 500 may be configured in othersuitable configurations.

Lead set hub 510 may be formed of soft pliable material. Lead set hub510 may include an adhesive or hydrogel patch or backing configured tohold the lead set hub 510 against the patient. Cable 540 connects leadset hub 510 to an ECG monitor (not shown) or to an ECG monitor adapter(not shown) configured to make ECG lead set 500 compatible with anotherwise non-compatible ECG monitor.

FIG. 5B illustrates a portion of a stretchable ECG electrode lead 560 ewith an undulating shaped wire 561 e held between two stretchableattached insulating layers 562, 563, and forming a chamber 566. As thestretchable ECG electrode lead 560 e is stretched, insulating layers562, 563 stretch to the new length and at least a portion of theundulating shaped wire 561 e within the chamber 566 between theinsulating layers 562, 563 may straighten.

FIG. 5C illustrates a portion of stretchable ECG electrode lead 560 fwith a zigzag shaped wire 561 f. As the stretchable ECG electrode leads560 f is stretched, at least a portion of the zigzag shaped wire 561 fstraightens.

FIG. 5D illustrates the addition of shielding layer 567 to stretchableECG electrode lead 560 g of FIG. 5B. Shielding layer 567 may be formedfrom a stretchable mesh material with sufficient EMI shieldingproperties. Alternatively, undulating shaped wire 561 may include ashield.

FIG. 6 illustrates yet another embodiment of an ECG lead set assembly600 of the present disclosure. ECG lead set assembly 600 includes leadset hub 610, at least one ECG electrode lead and a cable configured toconnect the ECG lead set assembly 600 to an ECG monitor (not shown) orto ECG monitor adapter 690. ECG lead set assembly 600 is configured havethe 5 electrodes 621 a-e positioned in a 5 lead configuration. ECG leadset assembly 600 may be configured for other suitable configurations.

Lead set hub 610 includes at least one clamp receptacle 680 a-econfigured to receive an ECG electrode lead 620 a-d. Clamp receptacle680 a-e includes a receptacle lever 681 a-e hingedly attached to leadset hub 610 by receptacle pin 682 a-e. ECG electrode lead 620 a-e isfixedly disposed in clamp receptacle 680 a-e when the receptacle lever680 a-e is in a clamped or actuated position, as illustrated in FIG. 6.

FIG. 7A is an exploded view of ECG electrode lead 620 of FIG. 6. ECGelectrode lead 620 includes electrode tab 670 and flexible tail 671which is about 12″ to 18″ in length. ECG electrode lead 620 is formedfrom substrate 672 at least partially covered with conductive inkcoating 673, conductive adhesive hydrogel layer 674, insulating layer675 and releasable liner 676. Conductive ink coating 673 is applied to,or printed on, substrate 672. Conductive ink coating 673 covers asubstantial portion of the electrode tab 670 and forms a continuousstrip down the center of substrate 675 from the electrode tab 670 to theproximal end of tail 671. Conductive adhesive hydrogel layer 674 isdisposed on conductive ink coating 673 on electrode tab 670 andinsulating layer 675 is disposed on conductive ink coating 673 on tail671. Adhesive hydrogel layer 674 may be covered with a releasable liner676.

Insulating layer 674 may be partially coated with a second adhesivelayer (not shown) to adhere the ECG electrode assembly 620 to patientand maintain a low profile and to minimize lead movement.

ECG electrodes lead 620 may be manufactured as illustrated in FIG. 7B.Manufacturing ECG electrode lead 620 with tip 670 to tail 671 eliminateswaste material. ECG electrode leads 620 may be die-cut into individualunits or a perforated cut between ECG electrode leads 620 may allowclinician to remove ECG electrode leads 620 as needed.

In FIG. 8 receptacle lever 680 a-e is in an up position and ECGelectrode lead 620 a-e is slidably disposed in clamp receptacle 680. ECGelectrode lead 620 is disposed between diamond plate 683 and lowerportion of receptacle lever 681. Diamond plate 683 is electricallyconnected to receptacle conductor 686 through ring termination 685 andrivet 684. Actuation or movement of the receptacle lever 681 about pivotpin 682 from an up position to a down position, as indicated by thecurved arrow, presses a portion of the ECG electrode lead 680 againstthe diamond plate 683.

With reference to FIGS. 6 and 8, to lock ECG electrode assembly 620 inplace, receptacle lever 681 is engaged to press at least a portion oftail 671 against the diamond plate 683, abrading or puncturing theinsulating layer 675 and exposing at least a portion of the conductiveink coating 673 on tail 671. The exposed portion of conductive inkcoating 671 makes electrical contact with diamond plate 683 therebyforming a connection between ECG electrode assembly 620 and receptacleconductor 686 through the diamond plate 683, rivet 684 and ringtermination 685. When receptacle lever 681 is fully rotated, the excesstail 671 material is cut and may be removed.

In yet another embodiment of the present disclosure, connection point isa plastic buckle that has an elliptical hole in its mid section. Affixedto the base of the hub under the buckle is an elliptical post. Amulti-conductor flex circuit has its conductors branch out to eachconnection point. At the end of each flex circuit branch is anelliptical hole with conductive ink around its circumference that ispositioned at the base of the elliptical post. The tail end of the leadalso has an elliptical hole with conductive ink around its circumferencethat loads onto the post, lying on top of the flex circuit branch. Afterthe lead is loaded onto the post, the buckle is snapped down,sandwiching the end of the lead tail against the flex circuit conductor.

In a further embodiment of the present disclosure, cable 640 of the ECGadapter system 300 may include a plurality of layers to electricallyshield the wires of the web 360 from electrical interference or noise.Alternatively, lead wires 320 a-320 e that form the web 360 may beindividually shielded.

FIGS. 9 and 10A-10D illustrate an alternate embodiment of an electrodelead set assembly 700 of the present disclosure. Lead set assembly 700includes lead set hub 710 and a plurality of electrode leads 712extending from the lead set hub 710. Lead set hub 710 includes aplurality of retractable reels 714 which permit selective extension andretraction of individual electrode leads via an access hole in the hub.Alternatively, a hand crank can be positioned with respect to the leadset hub 710 to simultaneously wind the reels 714. Lead set hub 710optionally has belt 716 attached thereto which is adapted for couplingto the patient “p” (e.g., about the torso or limb) to secure lead setassembly 700 relative to the patient “p”. Belt 716 may be elastic orhave a buckle (not shown) for length adjustment. Alternative means offixation of the hub to the patient include an adhesive patch on thebottom of the hub or an adhesive hydrogel that permits repositioningwithout loosing significant tack. FIGS. 10A-10C illustrate oneembodiment of lead set hub 710. In this embodiment, three reels 714 withelectrode leads 712 are incorporated within the lead set hub 710 andarranged in stacked relation as shown. Reels 714 each may incorporate alight spring mechanism to provide for automatic retraction of electrodeleads 712 and may further incorporate a releasable stop mechanism toreleasably secure an electrode lead 712 at a predetermined length. Suchreel mechanisms have automatic retraction and/or releasable securementcapabilities are appreciated by one skilled in the art. As illustratedin FIG. 10D, the lower surface of lead set hub may have recess 718 toaccommodate cable 720 which leads to the monitor. This presents a flatsurface upon which lead set hub 710 may be positioned relative to thepatient. Reels 714 may revolve about a central column. Alternatively,lead set hub 710 may be devoid of a central post or column. With thisarrangement, stacked reels 714 may be retained within lead set hub 710and spin within the lead set hub 710 as constrained by the internalsurface of the hub 710, i.e., not about a central post or column. Withthis arrangement, lead set hub 710 includes a central opening where thecolumn or post would reside. The opening is in axial alignment with thecentral openings of stacked reels 714. Recess or channel 718 receivesthe lead wires of cable 720 which extend up through the central openingfor connection to their respective reels. The respective lead wiresextend as a group from recessed channel 718 to a jacket or overmoldedpiece and eventually to a monitor connector. Through removal of acentral post, the dimensioning of lead set hub 702 may be minimized.

FIGS. 11-12 illustrate an alternate embodiment where lead set hub 702 isprovided with central post 722 around which stacked reels 714 (see,e.g., FIG. 10A) spin. Central post 714 includes individual conductiveelements 724 extending from base 726 of the central post 714. Conductiveelements 724 are arranged at different heights in alignment with aspecific reel 714 to contact the respective reel 714, i.e., eachconductive element 724 is assigned to a specific reel 714 and ispositioned to electrically contact with a corresponding inner contactsurface of the respective reel 714. Preferably, each conductive element724 incorporates projecting contact element 726 which contacts a contactsurface of a reel 714. The remaining portion of conductive element 724is recessed to avoid contact with the remaining reels 714 in lead sethub 702.

FIG. 13 illustrates an alternate embodiment where the reels 800 arepositioned within lead set hub 810 in side by side relation.

While several embodiments of the disclosure have been shown in thedrawings and/or discussed herein, it is not intended that the disclosurebe limited thereto, as it is intended that the disclosure be as broad inscope as the art will allow and that the specification be read likewise.Therefore, the above description should not be construed as limiting,but merely as exemplifications of particular embodiments. Those skilledin the art will envision other modifications within the scope and spiritof the claims appended hereto.

What is claimed is:
 1. An ECG lead set apparatus, which comprises: alead set hub adapted for electrical connection to a biomedical device;and at least one lead wire having hub end for releasable connection tothe lead set hub and an electrode at another end for receivingbiopotential signals from the patient, the biopotential signals beingtransmittable through the lead set hub to provide biomedical informationto biomedical device.
 2. The ECG lead set assembly according to claim 1including a plurality of lead wires, each lead wire having an electrode.3. The ECG lead set assembly according to claim 2 wherein the at leastone lead wire defines an effective length between the hub connector andthe electrode, the effective length being adjustable.
 4. The ECG leadset assembly according to claim 3 including a slide adjuster mountedabout the lead wire, the slide adjuster adapted to slide along the leadwire to adjust the effective length.
 5. The ECG lead set assemblyaccording to claim 4 wherein the slide adjuster is a buckle member. 6.The ECG lead set assembly according to claim 4 including at least twoslide adjusters.
 7. The ECG lead set assembly according to claim 1wherein the at least one lead wire is extensible.
 8. The ECG lead setassembly according to claim 3 wherein the at least one lead wireincludes a general serpentine arrangement adapted to flex toward alinear arrangement to thereby adjust the effective length thereof. 9.The ECG lead set assembly according to claim 8 wherein the at least onelead wire is encased within an insulative cover.
 10. The ECG lead setassembly according to claim 9 wherein the at least one wire is adaptedto flex toward the linear arrangement within the insulative cover. 11.The ECG lead set assembly according to claim 10 wherein the insulativecover is adapted to stretch.
 12. The ECG lead set assembly according toclaim 3 wherein the lead set hub includes an electrode mounted thereto.13. The ECG lead set assembly according to claim 3 including a pluralityof electrodes mounted to the lead set hub.
 14. The ECG lead set assemblyaccording to claim 3 further including an electrode array connectable tothe lead set hub, the electrode array including a substrate and aplurality of electrodes mounted to the substrate.
 15. The ECG lead setassembly according to claim 1 including a clamp mounted to the lead sethub, the clamp having a receptacle for reception of the hub end of theat least one lead wire, the clamp movable from an initial position to aclamping position to secure the hub end of the at least one lead wire tothe lead set hub and establish electrical connection between theelectrode and the biomedical device.
 16. The ECG lead set assemblyaccording to claim 15 wherein the clamp includes a conductive terminaladapted to electrically contact the at least one lead wire upon movementof the clamp to the clamping position.
 17. The ECG lead set assemblyaccording to claim 16 wherein the at least one lead wire includes aninsulating cover, the clamp including a penetrating member adapted topenetrate the insulating cover upon movement of the clamp to theclamping position to permit the conductive terminal to electricallycontact the at least one lead wire.
 18. The ECG lead set assemblyaccording to claim 17 wherein the penetrating member is adapted to severthe at least one lead wire upon movement of the clamp to the clampingposition.
 19. The ECG lead set assembly according to claim 1 including areel disposed within the lead set hub and housing the at least one leadwire, the at least one lead wire being releasable from the reel to varythe effective length between the electrode and the lead set hub.
 20. AnECG lead set assembly, which comprises: an ECG electrode assemblyincluding: at least one electrode configured to receive biopotentialsignals from a patient; a plug connector for connecting said ECGelectrode assembly; a web, connected between said at least one electrodeand said plug connector, configured to form an electrical connectiontherebetween; and a lead set hub, including at least one receptacle,wherein said at least on receptacle is configured to receive said plugconnector of said ECG electrode assembly;
 21. The ECG lead set accordingto claim 20 wherein said ECG electrode assembly includes at least oneslide adjuster, disposed on said web, said at least one slide adjusterconfigured to adjust the length of said ECG electrode assembly.
 22. TheECG lead set according to claim 20 wherein said at least one slideadjuster positions said web.
 23. The ECG lead set according to claim 20wherein said ECG electrode assembly includes at least one buckleadjuster to adjust the length of said ECG electrode assembly.
 24. An ECGelectrode assembly, which comprises: a substrate including a tab portionand a tail portion; a conductive layer disposed on at least a portion ofsaid tab portion and at least a portion of the center of said tailportion; a conductive adhesive layer disposed on said conductive layerdisposed on at least a portion of said tab portion; an insulating layerdisposed on said tail portion; wherein said insulating layer isconfigured to tear and expose said conductive layer in order to make anelectrical contact thereto.
 25. An ECG lead set which comprises: an ECGelectrode assembly including: a substrate including a tab portion and atail portion; a conductive layer disposed on at least a portion of saidtab portion and at least a portion of the center of said tail portion;an conductive adhesive layer disposed on said conductive layer disposedon at least a portion of said tab portion; an insulating layer disposedon said tail portion; and a lead set hub, including at least one clampreceptacle configured to receive said tail portion of said ECG electrodeassembly; and wherein said clamp receptacle of said lead set isconfigured to pierce said insulating layer and connect said conductivelayer of said ECG electrode assembly.